An Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects

Clinical studies are included in almost all new devices presented for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) and may also apply to the approximately 10% of devices under premarket notification that contain clinical data. ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects addresses the practical aspects of how to plan clinical investigations conducted in human subjects and defines procedures for the design, conduct, recording, and reporting of a clinical study. The latest version of the standard has been updated to provide step-by-step guidance on the creation and execution of a clinical study. This webinar will address good clinical practice in clinical investigations of medical devices for human subjects using ISO 14155 as a guide.